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FDA Will Ask Sarepta to Halt Gene Therapy Shipments

Sarepta says it won't comply with FDA request to stop shipping gene therapy Elevidys

U.S. regulators asked Sarepta Therapeutics on Friday to voluntarily halt shipments of its Elevidys gene therapy after a muscular dystrophy patient who received a different, experimental treatment died,

Associated Press News on MSN · 1d

Gene therapy maker Sarepta tells FDA it won’t halt shipments despite patient deaths

Drugmaker Sarepta Therapeutics says it won’t comply with a request from U.S. regulators to halt all shipments of its gene therapy.

Bloomberg on MSN · 1d

Sarepta Refused FDA’s Request to Halt Elevidys Shipments

Sarepta Therapeutics Inc. has refused to pause all shipments of its Elevidys treatment after three deaths were linked to the company’s gene therapies, the Food and Drug Administration said Friday.

Juul, FDA and menthol

Politico · 1d

FDA makes Juul’s reign official

JUUL GETS ITS CROWN — The FDA authorized Juul’s applications on Thursday to sell e-cigarettes in the U.S., determining they’re “appropriate for the protection of public health” because their benefits to adult smokers of combustible cigarettes outweigh the risks to nonsmoking youths.

Reuters on MSN · 2d

FDA approves Juul's tobacco and menthol e-cigarettes

The U.S. Food and Drug Administration has authorized the sale of Juul Labs' e-cigarette device and refill cartridges in tobacco and menthol flavors, after years of struggle with heightened regulatory scrutiny,

Associated Press News on MSN · 2d

Juul gets FDA’s OK to keep selling tobacco and menthol e-cigarettes

Federal health officials will allow Juul to keep selling its electronic cigarettes. The Food and Drug Administration said Thursday that Juul's benefits as a less harmful alternative for adult smokers outweigh the risks of teen use.

1hon MSN

FDA commissioner touts MAHA wins after major brands pledge synthetic dye swap

Food and Drug Administration Commissioner Dr. Marty Makary joins 'Fox & Friends Weekend' to discuss the MAHA push as major brands pledge to remove synthetic dyes.

2don MSN

FDA Issues Risk Warning for Ice Cream Recalled in 23 States

Rich Ice Cream Co. recalled numerous lots of its products on June 27 over potential contamination with Listeria monocytogenes ...

FDA Plans to Revoke 52 Food Standards

The 52 food standards pertain to canned fruits and vegetables, dairy products, baked goods, macaroni products, and other ...

Hoodline1h

Sarepta Therapeutics Announces Layoff of 493 Employees, Including 80 in Ohio, Amid FDA Scrutiny and Stock Decline

Sarepta Therapeutics lays off 493 workers amid FDA probe, stock drop, and concerns over its gene therapy treatment, Elevidys.

2don MSN

FDA recalls over 67,000 cases of Power Stick deodorant. See where products were sold

The manufacturer announced a recall of 67,214 cases of its Power Stick roll-on deodorant due to violations of Current Good ...

1don MSN

US FDA advisers recommend against Otsuka's PTSD combination treatment

The U.S. Food and Drug Administration's panel of independent advisers on Friday voted against the efficacy of Otsuka Pharma's ...

The FDA's Newest Approval Could Have A Major Impact On Your Favorite Foods

Move over, artificial food colors, the FDA just approved gardenia (genipin) blue, a plant‑derived dye to shake up drinks and ...

FDA panel reassesses hormone therapy warnings in menopause treatments

The Food and Drug Administration is reassessing some warnings given about hormone therapy treatments for menopause that have ...

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FDA Will Ask Sarepta to Halt Gene Therapy Shipments

Juul, FDA and menthol

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